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Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00499993
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : December 22, 2009
Information provided by:

Brief Summary:
The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: lanreotide (Autogel formulation), duration of treatment 46-48 weeks Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly
Study Start Date : January 2001
Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Growth hormone assessment [ Time Frame: At every visit ]

Secondary Outcome Measures :
  1. Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments [ Time Frame: At every visit (with the exception of ALS at study inclusion) ]
  2. Prolactin (PRL) assessment [ Time Frame: At study inclusion, visit 1 and at the final visit of the study ]
  3. Lanreotide assessment [ Time Frame: At every visit ]
  4. Clinical symptoms [ Time Frame: At every visit ]
  5. Quality of life [ Time Frame: At visit 1 and at the final visit of the study ]
  6. Tumour size [ Time Frame: At inclusion and at the final visit of the study ]
  7. Evaluation of carotid vessels (on an optional basis) [ Time Frame: At inclusion and at the final visit of the study ]
  8. Safety assessment evaluated by clinical data [ Time Frame: At every visit ]
  9. Safety assessment evaluated by laboratory data [ Time Frame: At inclusion visit and at the final visit of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values

Exclusion Criteria:

  • Patients who have undergone pituitary surgery less than 3 months before selection
  • Patients previously treated with radiotherapy
  • Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499993

Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128
Ospedale Maggiore
Bologna, Italy, 40133
Clinica Medica - Sezione II Medicina Endocrinologia
Brescia, Italy, 25125
Università deglis Studi di Cagliari
Cagliari, Italy, 09124
Ospedale Garibaldi
Catania, Italy, 95123
Università degli Studi di Ferrara
Ferrara, Italy, 44100
Università degli Studi di Firenze
Firenze, Italy, 50134
D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche
Genova, Italy, 16100
Istituto Auxologico
Milano, Italy, 20100
Ospedale Maggiore IRCCS
Milano, Italy, 20122
Ospedale di Niguarda Cà Granda
Milano, Italy, 20162
Università "Federico II" di Napoli
Napoli, Italy, 80131
Ospedale "S. Luigi Gonzaga"
Orbassano (to), Italy, 10043
Università degli Studi di Padova
Padova, Italy, 35128
Azienda Ospedaliera "V. Cervello"
Palermo, Italy, 90148
Ospedale Cisanello
Pisa, Italy, 56100
Servizio di Endocrinologia
Reggio Emilia, Italy, 42100
Università "La Sapienza" di Roma
Roma, Italy, 00161
Policlinico Agostino Gemelli
Roma, Italy, 00168
Istituto di Patologia Speciale Medica e Metodologia Clinica
Sassari, Italy, 07199
Università degli Studi di Ancona, Ospedale Umberto I
Sede Di Torrette (an) Ancona, Italy, 60020
Ospedale Molinette
Torino, Italy, 10126
Ospedale Cà Foncello
Treviso, Italy, 31100
Ospedale Santa Maria della Misericordia
Udine, Italy, 33100
Sponsors and Collaborators
Study Director: Paolo Boscani, MD Ipsen

ClinicalTrials.gov Identifier: NCT00499993     History of Changes
Other Study ID Numbers: A-93-52030-077
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: December 22, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs